Lidocaine 5% Medicated Plaster in Chronic Neuropathic Postoperative Pain

NCT ID: NCT01155986

Last Updated: 2019-10-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2012-11-30

Brief Summary

The purpose of this trial is to investigate the efficacy and safety of lidocaine 5% medicated plaster in localized chronic post-operative neuropathic pain in comparison to placebo plaster.

Detailed Description

Some patients who undergo different types of surgery develop distressing and long-lasting pain. This pain is often characterized by signs such as: allodynia (a pain due to a stimulus which does not normally provoke pain), dysesthesia (unpleasant, abnormal sense of touch). Patients describe symptoms of burning or electrical type sensation. In some cases this type of chronic pain can still be present after 3 months or more following surgery.This clinical trial will assess the efficacy and safety profile of lidocaine 5% medicated plaster in comparison to placebo plaster in patients.

This trial is a randomized, double-blind (neither investigator nor patient will know which treatment was received), placebo-controlled, parallel-group, multicenter trial to evaluate topical analgesic treatment of chronic neuropathic pain after surgery. The trial will include a screening phase and a treatment phase, during which subjects will be treated with either 5% lidocaine medicated plaster, or a placebo plaster pain intensity will be assessed on a daily basis. Subsequently there will be a follow-up phase. Pain intensity numeric rating scale (PI) will be collected via the numeric rating scale and averaged. Safety evaluations include monitoring of adverse events, physical examinations, and clinical laboratory tests.

Conditions

Pain; Chronic Pain; Neuropathic Pain; Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo Plaster

Active Comparator

Group Type: PLACEBO_COMPARATOR

Placebo topical plaster

Intervention Type: DRUG

Topical hydrogel plaster

Lidocaine Plaster

Group Type: ACTIVE_COMPARATOR

Lidocaine 5% medicated plaster

Intervention Type: DRUG

Topical hydrogel plaster (700mg lidocaine)

Interventions

Lidocaine 5% medicated plaster

Topical hydrogel plaster (700mg lidocaine)

Intervention Type: DRUG

Placebo topical plaster

Topical hydrogel plaster

Intervention Type: DRUG

Other Intervention Names

Versatis(R)

Eligibility Criteria

Inclusion Criteria

• Male or female subjects with >= 18 years of age
• Intact skin in the area of topical treatment
• Patients suffering from moderate to severe ( 5 or more points on an 11 point Numerical Rating Scale where 10 is the worst possible pain, and 0 indicates no pain) chronic daily postoperative neuropathic pain for the past 6 to 24 months.
• Patients should have symptoms for example allodynia (a pain due to a stimulus which does not normally provoke pain); and or dysesthesia (unpleasant, abnormal sense of touch).

Exclusion Criteria

• Contraindications to lidocaine 5% medicated plaster, or paracetamol
• Evidence or history of alcohol, medication or drug abuse and/or dependency in the past 3 years.
• Evidence or history (during the past 3 years) of epilepsy, neurotic personality, psychiatric illness, or suicide risk.
• Pregnant or breastfeeding women
• Women of childbearing potential who are sexually active without satisfactory contraception for at least 28 days prior to enrollment, during the trial, and until 28 days after the follow-up visit.
• Severe renal, hepatic or heart disorder.
• Surgery in the past 3 months before screening.
• Anticipated need for surgery during the trial, requiring at least regional or general anesthesia.
• Pending litigation due to chronic pain or disability.
• Participation in another trial of investigational medicinal products or devices parallel to or less than 1 month before entry into the trial, or previous participation in this trial.
• Presence of other severe pain that could confound the assessment or self- evaluation of the localized postoperative neuropathic pain.
• For patients with chronic postoperative neuropathic pain related to a surgery due to tumors: suspected residual tumor or metastases, chemotherapy or radiotherapy for treatment of tumor(s).
• Total anesthesia in the area of localized chronic pain

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grünenthal GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean Bruxelle

Role: PRINCIPAL_INVESTIGATOR

Fondation Ophtalmologique Adolphe de Rotschild, Service de Neurochirurgie, CEntre d'Evaluation et de Traitement de la Douleur

Locations

Site 31

Abbeville, , France

Site 26

Bayonne, , France

Site 34

Bobigny, , France

Site 35

Bordeaux, , France

Site 12

Boulogne-Billancourt, , France

Site 24

Brest, , France

Site 15

Châteauroux, , France

Site 30

Corbeil-Essonnes, , France

Site 39

La Roche-sur-Yon, , France

Site 23

Lille, , France

Site 17

Limoges, , France

Site 21

Marseille, , France

Site 33

Montauban, , France

Site 14

Nice, , France

Site 18

Orléans, , France

Site 27

Paris, , France

Site 36

Paris, , France

Site 22

Rennes, , France

Site 20

Saint-Etienne, , France

Site 19

Saint-Genis-Laval, , France

Site 38

Tours, , France

Site 28

Voiron, , France

Countries

France

Other Identifiers

2009-016337-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

761541

Identifier Type: -

Identifier Source: org_study_id